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Open Data

Healthcare Data Institute : Unlocking the full potential of data analytics for the benefit of all

Pharma Compliance Info Healthcare Data Institute : Unlocking the full potential of data analytics for the benefit of all Open Data

Although current debates on healthcare data often focus overly on potential risks and misuses of the data, benefits to be reaped from extending healthcare data usage are in fact immense. A multitude of use cases are there to prove the extensive value being created by data analytics, across all stakeholders of the healthcare system, including patients, healthcare professionals and providers, payers, researchers, biopharma and medical device companies, regulators and healthcare authorities.“ To download the Healthcare Data Institute White Paper: Unlocking the full potential of data analytics for the benefit of all

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EMA Announces Publication of Clinical Trial Reports By Middle of 2016

Pharma Compliance Info EMA Announces Publication of Clinical Trial Reports By Middle of 2016 Open Data

The European Medicines Agency (EMA) bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. On 1 January 2015 a new EMA policy on publication of clinical data entered into force. Under this policy, the Agency proactively publishes the clinical reports submitted as part of marketing-authorisation applications for human medicines. Since 2010 the Agency has been releasing clinical-trial reports on request, under its access-to-documents policy. The Agency is committed to continuously extending its approach to transparency. A key goal in this process is the publication of clinical-trial data for medicines once the decision-making …

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Données de santé: les sénateurs réécrivent l’article 47 du projet de loi de santé

Pharma Compliance Info Données de santé: les sénateurs réécrivent l'article 47 du projet de loi de santé Open Data

Les sénateurs ont adopté jeudi après deux heures de débats l’article 47 du projet de loi de santé relatif à la gestion et à la mise à disposition des données de santé, déjà sensiblement réécrit en juillet par la commission des affaires sociales. Après avoir examiné les deux premiers titres du projet de loi du 14 au 18 septembre, les sénateurs ont repris lundi dernier l’examen en première lecture du texte adopté en avril par l’Assemblée nationale. Il vote solennel du texte est prévu mardi. La ministre des affaires sociales, de la santé et des droits des femmes, Marisol Touraine, …

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EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law

Pharma Compliance Info EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law Open Data

Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016. The release of the reports comes as EMA’s policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers have notified EMA of the withdrawal of a marketing authorization application. In addition to the implementation of EMA’s transparency policy, the European Commission, EMA and World Health Organization announced Tuesday that …

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